Two years post-treatment, a prospective study report including 11 sites and 45 patients demonstrated statistically significant improvement in pain (VAS imp. 3.8 pts.) and mobility (ODI imp. 11.6 pts.) with no device or intra-procedure adverse events. This is the longest reported multi-center follow-up on patients treated with the mild procedure.

A systematic safety review and meta-analysis of mild procedural experience of 373 patients across 32 sites demonstrated that there were no reports of major device or procedure-related adverse events. The study also showed statistically significant improvement in pain (VAS imp. 3.9 pts.) and mobility (ODI imp. 16.0 pts.) in 134 patients at one year.

One year post-treatment, a single-site, 46-patient, prospective study demonstrated statistically significant improvement in pain (VAS imp. 2.9 pts.) and mobility (ODI imp. 17.4 pts.) with no reports of major device or procedure-related adverse events. One-year follow-up was not significantly different from interim results, indicating that improvement following treatment as early as 12 weeks was maintained through one year.

A single-site, 42 patient, retrospective study demonstrated statistically significant improvement in pain (VAS imp. 3.8 pts.) and improvement in function as assessed by ability to stand and ambulate, with no device or procedure-related major adverse events.

A review of the technique and current literature regarding the efficacy and safety of the mild procedure. Patient outcomes post-mild were statistically significantly improved in both pain intensity and physical function, with excellent safety results and no major device- or procedure-related complications. Compared to published decompressive surgery safety results, mild patients experienced comparable outcomes with significantly fewer serious related adverse events.

Current literature review regarding the efficacy, safety, and cost-effectiveness of the mild procedure with comparison to surgical treatment demonstrated a similar level of symptom relief and a significantly better safety profile with mild.

A review of the current literature regarding the efficacy, safety, and cost-effectiveness of the mild procedure concluded that pain can be safely, and effectively reduced and functionality improved, with minimal change of spinal biomechanics and stability in LSS patients.

A single-site, 14-patient, prospective study of high-risk surgical patients demonstrated a statistically significant improvement in VAS scores with a reduction in pain of 53% (VAS imp. 3.9 pts.) at an average 23.5 weeks following the procedure compared with preoperative levels. The ODI score improvement was not statistically significant. The lack of improvement in ODI scores was not surprising, given the fact that many of the patients had physiologically limiting coexistent issues, such as oxygen-dependent pulmonary fibrosis, prior stroke, and systemic malignancies.